Acumen Pharmaceuticals Announces First Subject Dosed in Phase 1 Study of Subcutaneous Sabirnetug (ACU193) for Early Alzheimer’s Disease
Acumen Pharmaceuticals (NASDAQ: ABOS) has announced the dosing of the first subject in a Phase 1 study of subcutaneous sabirnetug (ACU193) for early Alzheimer's disease. The study aims to compare the pharmacokinetics between subcutaneous and intravenous administrations in healthy volunteers. Sabirnetug, co-formulated with Halozyme's ENHANZE® technology, targets soluble amyloid beta oligomers (AβOs) in the brain.
The subcutaneous formulation is designed to provide a more convenient and accessible option for patients, potentially improving treatment adherence. Acumen is also currently conducting the ALTITUDE-AD Phase 2 trial to evaluate the efficacy and safety of intravenous sabirnetug in early AD patients. Previous Phase 1 results showed favorable safety, target engagement, and amyloid plaque reduction comparable to approved therapies.
Acumen Pharmaceuticals (NASDAQ: ABOS) ha annunciato la somministrazione del primo soggetto in uno studio di Fase 1 sul sabirnetug sottocutaneo (ACU193) per la malattia di Alzheimer precoce. Lo studio punta a confrontare la farmacocinetica tra somministrazioni sottocutanee e endovenose in volontari sani. Sabirnetug, co-formulato con la tecnologia ENHANZE® di Halozyme, mira agli oligomeri solubili di beta-amiloide (AβOs) nel cervello.
La formulazione sottocutanea è progettata per offrire un'opzione più comoda e accessibile per i pazienti, migliorando potenzialmente l'aderenza al trattamento. Acumen sta anche conducendo il trial di Fase 2 ALTITUDE-AD per valutare l'efficacia e la sicurezza del sabirnetug endovenoso in pazienti con Alzheimer precoce. I risultati precedenti della Fase 1 hanno mostrato una favorevole sicurezza, coinvolgimento target e riduzione delle placche amiloidi comparabili a terapie approvate.
Acumen Pharmaceuticals (NASDAQ: ABOS) ha anunciado la dosificación del primer sujeto en un estudio de Fase 1 del sabirnetug subcutáneo (ACU193) para la enfermedad de Alzheimer temprana. El estudio tiene como objetivo comparar la farmacocinética entre las administraciones subcutáneas e intravenosas en voluntarios sanos. Sabirnetug, coformulado con la tecnología ENHANZE® de Halozyme, se dirige a los oligómeros solubles de beta-amiloide (AβOs) en el cerebro.
La formulación subcutánea está diseñada para proporcionar una opción más conveniente y accesible para los pacientes, potencialmente mejorando la adherencia al tratamiento. Acumen también está llevando a cabo el ensayo de Fase 2 ALTITUDE-AD para evaluar la eficacia y seguridad del sabirnetug intravenoso en pacientes con Alzheimer temprano. Los resultados previos de la Fase 1 mostraron una seguridad favorable, compromiso del objetivo y reducción de placas de amiloide comparable a las terapias aprobadas.
아큐멘 제약( NASDAQ: ABOS )은 초기 알츠하이머병 치료를 위한 피하 사비르네투그(ACU193)의 제1상 연구에서 첫 번째 피험자의 투여를 발표했습니다. 이 연구의 목적은 건강한 자원자들 사이에서 피하 및 정맥 투여의 약물 동태를 비교하는 것입니다. 사비르네투그는 할로자임의 ENHANZE® 기술과 함께 공동 조제되어 뇌의 용해성 아밀로이드 베타 올리고머(AβOs) 표적을 설정합니다.
피하 제형은 환자에게 더 편리하고 접근 가능한 옵션을 제공하여 치료 순응도를 향상시키는 것을 목표로 설계되었습니다. 아큐멘은 또한 초기 AD 환자의 정맥 사비르네투그의 효능 및 안전성을 평가하기 위해 ALTITUDE-AD 제2상 시험을 진행 중입니다. 이전 제1상 결과는 승인된 치료와 비교할 때 우호적인 안전성, 표적 참여 및 아밀로이드 플라크 감소를 보여주었습니다.
Acumen Pharmaceuticals (NASDAQ: ABOS) a annoncé l'administration du premier sujet dans une étude de phase 1 sur le sabirnetug sous-cutané (ACU193) pour la maladie d'Alzheimer précoce. L'étude vise à comparer la pharmacocinétique entre les administrations sous-cutanées et intraveineuses chez des volontaires en bonne santé. Sabirnetug, co-formulé avec la technologie ENHANZE® de Halozyme, cible les oligomères solubles de beta-amyloïde (AβOs) dans le cerveau.
La formulation sous-cutanée est conçue pour offrir une option plus pratique et accessible pour les patients, améliorant potentiellement l'adhésion au traitement. Acumen mène également l'essai de phase 2 ALTITUDE-AD pour évaluer l'efficacité et la sécurité du sabirnetug intraveineux chez les patients atteints de la maladie d'Alzheimer précoce. Les résultats précédents de la Phase 1 ont montré une sécurité favorable, un engagement cible et une réduction des plaques amyloïdes comparables aux thérapies approuvées.
Acumen Pharmaceuticals (NASDAQ: ABOS) hat die Dosisgabe des ersten Probanden in einer Phase-1-Studie zu subkutanem Sabirnetug (ACU193) für die frühe Alzheimer-Krankheit bekannt gegeben. Die Studie zielt darauf ab, die Pharmakokinetik zwischen subkutanen und intravenösen Verabreichungen bei gesunden Freiwilligen zu vergleichen. Sabirnetug, das gemeinsam mit der ENHANZE®-Technologie von Halozyme formuliert wurde, richtet sich an lösliche Amyloid-Beta-Oligomere (AβOs) im Gehirn.
Die subkutane Formulierung ist darauf ausgelegt, den Patienten eine bequemere und zugänglichere Option zu bieten, was die Therapieadhärenz potenziell verbessern könnte. Acumen führt auch die ALTITUDE-AD Phase-2-Studie durch, um die Wirksamkeit und Sicherheit von intravenösem Sabirnetug bei Patienten mit frühem Alzheimer zu bewerten. Frühere Ergebnisse der Phase 1 zeigten eine günstige Sicherheit, Zielbindung und Reduktion von Amyloid-Plaques, die mit zugelassenen Therapien vergleichbar sind.
- First subject dosed in Phase 1 study of subcutaneous sabirnetug for early Alzheimer's disease
- Subcutaneous formulation aims to improve treatment adherence and accessibility
- Phase 1 INTERCEPT-AD trial showed favorable safety profile and statistically significant amyloid plaque reduction
- Currently enrolling patients in Phase 2 ALTITUDE-AD study for intravenous sabirnetug
- None.
Insights
The initiation of a Phase 1 study for a subcutaneous formulation of sabirnetug (ACU193) marks a significant milestone in Acumen Pharmaceuticals' Alzheimer's disease (AD) research pipeline. This development could potentially revolutionize AD treatment delivery methods, addressing key challenges in patient adherence and accessibility.
Key points to consider:
- The subcutaneous formulation utilizes Halozyme's ENHANZE® technology, which has been validated in eight approved therapies. This established track record lends credibility to the approach and may reduce development risks.
- Sabirnetug's unique mechanism of action, targeting soluble amyloid beta oligomers (AβOs), differentiates it from other AD treatments. The selective targeting of AβOs, which are implicated in early AD pathology, could potentially offer a more precise therapeutic approach.
- The ongoing ALTITUDE-AD Phase 2 trial for the intravenous formulation will provide important efficacy data. Positive results could significantly boost investor confidence in the subcutaneous formulation's potential.
- Previous Phase 1 results (INTERCEPT-AD) demonstrated a favorable safety profile with low rates of ARIA-E, a common side effect in amyloid-targeting therapies. This safety advantage, if maintained, could be a major differentiator in the competitive AD treatment landscape.
While the subcutaneous formulation is still in early-stage development, its potential to improve treatment adherence and accessibility could significantly enhance sabirnetug's market prospects if approved. Investors should closely monitor the progress of both the subcutaneous and intravenous formulations, as positive outcomes could position Acumen as a strong player in the lucrative AD treatment market.
Acumen Pharmaceuticals' advancement of a subcutaneous formulation for sabirnetug represents a strategic move in the competitive Alzheimer's disease (AD) treatment landscape. This development has several implications for the company's market position and potential commercial success:
- Differentiation strategy: By offering a more convenient administration route, Acumen could gain a competitive edge over other AD treatments that require intravenous infusion or in-office administration.
- Market expansion potential: A subcutaneous formulation could broaden the patient population by making treatment more accessible, particularly for patients who have difficulty with frequent hospital visits.
- Partnership validation: The collaboration with Halozyme for the ENHANZE® technology demonstrates Acumen's ability to form strategic partnerships, which is important for small biotech companies.
- Pipeline diversification: By developing both intravenous and subcutaneous formulations, Acumen is creating a more robust product portfolio, potentially mitigating risk and appealing to a broader range of healthcare providers and patients.
However, investors should note that success is not guaranteed. The AD treatment market is highly competitive, with several large pharmaceutical companies developing their own therapies. Acumen will need to demonstrate superior efficacy, safety, or convenience to capture significant market share.
Furthermore, the company's financial position and burn rate should be closely monitored, as the development of multiple formulations and ongoing clinical trials can be capital-intensive. Positive clinical results and progression through development stages will be critical for maintaining investor confidence and potentially securing additional funding or partnerships.
In conclusion, while the subcutaneous formulation development is a positive step, it's part of a longer journey in a challenging therapeutic area. Investors should balance the potential upside with the inherent risks of early-stage biotech investments in the AD space.
NEWTON, Mass., July 29, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) in the brain for the treatment of Alzheimer’s disease (AD), today announced that the first subject has been dosed with a subcutaneous formulation of sabirnetug (ACU193) in a Phase 1 pharmacokinetic (PK) comparison study. The study plans to compare the PK between subcutaneous and intravenous administrations of sabirnetug in healthy volunteers.
Acumen’s subcutaneous formulation of sabirnetug is co-formulated with Halozyme’s proprietary ENHANZE® drug delivery technology (recombinant human hyaluronidase enzyme, rHuPH20) that enables large volumes of subcutaneous injection with increased dispersion and absorption of co-administered therapies. ENHANZE® has been commercially validated in eight approved therapies.
“With a subcutaneous formulation of sabirnetug, we aim to provide a more convenient and accessible option for patients with Alzheimer’s disease, which we believe will improve treatment adherence through enhanced flexibility for patients, caregivers and providers,” said Daniel O’Connell, Chief Executive Officer of Acumen. “We are strongly committed to advancing the underlying science and innovation of Alzheimer’s disease treatments, and we are excited about the potential of sabirnetug to make a meaningful impact on the lives of patients and their families.”
Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AβOs in AD patients. Soluble AβOs are a highly toxic form of Aβ that begin to accumulate before a clinical diagnosis of AD and are an early and persistent trigger of synaptic dysfunction and neurodegeneration. Acumen is developing sabirnetug as a potential next generation antibody treatment for early AD. The company is currently enrolling patients in the ALTITUDE-AD study, a Phase 2 clinical trial designed to evaluate the clinical efficacy and safety of intravenous sabirnetug in patients with early AD.
Topline results from the Phase 1 clinical trial INTERCEPT-AD indicated that intravenous administration of sabirnetug is well tolerated with a favorable overall safety profile, including low overall rates of ARIA-E. The trial showed compelling improvement of downstream biochemical biomarkers, evidence of target engagement supporting proof of mechanism, and statistically significant amyloid plaque reduction comparable to approved amyloid-directed therapies at similar time points.
For more information about Acumen Pharmaceuticals and its ongoing clinical trials, please visit www.acumenpharm.com.
About Sabirnetug (ACU193)
Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AβOs), which are a highly toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, sabirnetug aims to address the hypothesis that soluble AβOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD.
About INTERCEPT-AD (Phase 1)
Completed in 2023, INTERCEPT-AD was a Phase 1, U.S.-based, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and tolerability, and establishing clinical proof of mechanism, of sabirnetug in patients with early Alzheimer’s disease (AD). Sixty-five individuals with early symptomatic AD (mild cognitive impairment or mild dementia due to AD) enrolled in this first-in-human study of sabirnetug. The INTERCEPT-AD study consisted of single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts and was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and target engagement of intravenous doses of sabirnetug. More information can be found on www.clinicaltrials.gov, NCT identifier NCT04931459.
About Halozyme’s ENHANZE® Technology
Halozyme's commercially validated proprietary ENHANZE® drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume and delivery rates of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered rapidly in minutes subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections.
About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer’s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning the therapeutic potential of Acumen’s product candidate, sabirnetug (ACU193), including a subcutaneous formulation of sabirnetug in a Phase 1 PK study, and Acumen’s plans to complete a Phase 2 study of sabirnetug. These statements are based upon the current beliefs and expectations of Acumen’s management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s most recent Annual Report on Form 10-K, and in subsequent filings with the SEC. Copies of these and other documents are available from Acumen. Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise.
Investors:
Alex Braun
abraun@acumenpharm.com
Media:
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ICR Westwicke
AcumenPR@westwicke.com
FAQ
What is the purpose of Acumen Pharmaceuticals' Phase 1 study for sabirnetug (ACU193)?
How does sabirnetug (ACU193) target Alzheimer's disease?
What were the results of the INTERCEPT-AD Phase 1 trial for sabirnetug (ACU193)?
What is the current status of Acumen Pharmaceuticals' (ABOS) ALTITUDE-AD study?
